In February 2011, the FDA approved premature birth prevention drug, Makena, for public consumption. Makena is the first FDA approved drug of its kind created to reduce the risks of premature births in women who have previously delivered their babies prematurely.
Makena is a derivative of Delalutin, a progesterone hormone drug used to prevent preterm labor in pregnant women. However, the FDA discontinued Delalutin, because clinical trials suggested the drug increased miscarriages in women rather than preventing premature births.
Ideally, Makena will provide synthetic progesterone hormones, so that women will not deliver prematurely. Progesterone is a hormone that increases during pregnancy to support the viability of a growing fetus. With low levels of progesterone, pregnant women are at risk for premature births.
Pregnant advocacy groups and women alike expressed outrage against Ther-RX, a subsidiary of K-V Pharmaceutical Company and the manufacturer of Makena, for the high cost of the drug. Originally, Makena cost $1500 for one injection of the drug, an exorbitant amount for a pharmaceutical drug initially priced at $20 per injection.
Advocates complained that the high cost of Makena would prevent low-income women from having access to the drug. The lack of access would create extreme inequities in quality prenatal care considering that low income women are more susceptible to delivering premature babies, if they had a previous premature birth.
In response, Ther-RX established a Patient Assistance program for low-income patients to acquire access to their drug. Under the Patient Assistance program, eligible women can receive injections of the drug at no cost or at a low cost of no more than a $20 co-pay, depending on whether or not the women are insured and whether their incomes do not exceed $100,000.
For ineligible women, K-V Pharmaceutical Company originally charged $1500 each for 20 injections administered over the course of 20 weeks for a total of $30,000. After a swarm of numerous complaints, the corporation reduced the price of the drug to $690 with supplemental rebates through Medicaid.
Still, the extreme, original cost of Makena led the March of Dimes to withdraw its support from K-V Pharmaceutical Company. Further, the FDA provided competitors permission to produce generic versions of the drug, potentially eliminating a large portion of profits the corporation could have generated as the exclusive manufacturer of the drug.
The FDA decided to remove its “enforcement discretion” from compounded versions of Makena, since it supported widespread access to the important drug for all women regardless of their income. Essentially, K-V Pharmaceuticals increased its negative publicity and marketplace competition by setting the price of its drug “too high” according to many consumers.
Although, Makena is an orphan drug, or a drug exclusively manufactured by one producer for 7 years, the FDA contradicted its orphan status, when it said competitors can create generic versions or compound versions of Makena to sell to low-income populations. In essence, the FDA announcement has reduced the benefits of owning orphan drug status, because consumers have access to alternative versions of the drug, if they cannot afford it.
An issue less mentioned in this controversy is the safety of Makena against the risk of miscarriages which still remains questionable, especially since Makena contains similar chemical hormonal components of Delalutin, namely, the progesterone. Presently, Makena advertises the potential side effects of the drug as nausea, diarrhea, swelling, and the potential risks of blood clots due to the development of embolisms.
Thus far, the FDA’s approval of Makena demonstrates the need for pharmaceutical corporations to consider consumer feedback, when overpricing drugs that offer priceless benefits and create financial access limitations. Despite the controversy, at the least, the drug is more freely available to women with high risk pregnancies from premature births.
I honestly think that women should be careful in buying products for pregnancy, for lactating, and even in their daily skin and beauty routine. As for me, I always check reviews. Recently, I saw some vitamin c serum for face reviews and they are really helpful on someone who has no idea what she is buying. So women, always research!
Andrew Zajac. ” Drug maker lowers the price of Makena Pregnancy Drug to $690 per Dose,” LATimes.com.
Daniel DeNoon. “FDA: Pharmacies Can Still Make Preterm Birth Drug,” WebMD.com.
Jennifer Forst. “K-V Pharmaceutical Announces Patient Assistance Program,” K-V Pharmaceutical.com.
Steven Reinberg. “FDA Approves First Drug to Prevent Premature Births,” BusinessWeek.com.